FDA Updates

The approval follows positive results from the V005 (NCT03005418) clinical trial.

The rare genetic disease is a severe hypertriglyceridemia that can lead to potentially life-threatening acute pancreatitis.

Duloxetine is a commonly prescribed medication used to treat anxiety, depression, and other mental health disorders.

The indication is for patients with locally advanced or metastatic disease who have not previously received treatment with an ALK-inhibitor.

The approval makes remestemcel-L-rknd the first approved mesenchymal stromal cell in the United States.

Lerodalcibep is a third-generation PCSK9 inhibitor that demonstrated success in reducing low density lipoprotein cholesterol (LDL-C).

Clesrovimab would be the first and only single dose immunization indicated for infants regardless of weight, aimed to protect against their first RSV season.

The updated prescribing information recommends laboratory tests prior to prescribing fezolinetant to determine baseline for hepatic function and injury.

Ustekinumab-stba (Steqeyma; Celltrion) is a subcutaneous treatment for adult and pediatric patients with plaque psoriasis arthritis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The decision is based on positive results from the CAHtalyst trials, which both met their primary and secondary end points.

Abstract data presented in September demonstrate that the drug elicited strong antitumor activity in the second line in both platinum-sensitive and -resistant patients.

Based on positive results from the HERCULES trial, the new designation will allow for more thorough regulatory review and development of the multiple sclerosis treatment.

Nemolizumab exclusively targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.

The indication is for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation.

The approval builds on previous indications for tapinarof, an aryl hydrocarbon receptor agonist, for the topical treatment of atopic dermatitis.

The treatments are currently undergoing evaluation in the SOLSTICE trial (NCT05461170).

The pumps can now be used to treat pediatric patients who have symptomatic acute decompensated heart failure and cardiogenic shock.

Currently, the treatment is undergoing evaluation in a phase 2a trial.

This update follows May 2021 guidelines which recommended patients with primary biliary cholangitis (PBC) with advanced cirrhosis discontinue obeticholic acid.

The combination vaccine candidates will be evaluated in 2 separate phase 1/2 clinical trials.

PLT012 demonstrates its potential against multiple tumors with unmet medical needs.

Two studies found a 2-bag regimen of N-acetylcysteine (NAC) resulted in fewer and shorter delays in treatment as well as decreases in cutaneous non-allergic anaphylactoid reactions.

If approved, the treatment will be the first and only once-daily, oral selective somatostatin receptor type 2 nonpeptide agonist available for acromegaly.

As experts in medication management and health education, pharmacists can work with the administration to promote effective strategies that reduce misinformation and improve public health outcomes.

Durvalumab could offer further treatment for individuals with muscle-invasive bladder cancer.

Fabry disease is a rare lysosomal disorder that causes excessive deposition of lipids in tissues.

Zenocutuzumab-zbco is a bispecific antibody that targets and binds to HER2 and HER3.

The indication is for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based chemotherapy and radiation therapy.